Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations
Authors: Jeff S. Healey, Andrew D. Krahn, Jamil Bashir, Guy Amit, François Philippon, William F. McIntyre, Bernice Tsang, Jacqueline Joza, Derek V. Exner, David H. Birnie, Mouhannad Sadek, Darryl P. Leong, Markus Sikkel, Victoria Korley, John L. Sapp, Jean-Francois Roux, Shun Fu Lee, Gloria Wong, Angie Djuric, Danna Spears, Sandra Carroll, Eugene Crystal, Tom Hruczkowski, Stuart J. Connolly, Blandine Mondesert, Jeff S. Healey, Blandine Mondesert, Andrew D. Krahn, Jamil Bashir, Tim Stivland, Mark Mosley, Peter Aitkins, John Sapp, William F. McIntyre, Jason D. Roberts, Amir Janmohamed, Guy Amit, Francois Philippon, Andrew Epstein, John Cairns, Kevin Thorpe, Darryl P. Leong, Naif Saad, Harry Klimis, Felipe Cirne, Osama Eltebi, Aditya Khetan, Tais Araujo, Hisham Dokainish, Guy Amit, Bernice Tsang, Jacqueline Joza, Derek V. Exner, David H. Birnie, Mouhannad Sadek, Chris Lane, Marc Dubuc, Vidal Essebag, Darryl Leong, Markus Sikkel, Victoria Korley, Benoît Plourde, Bernard Thibault, John Sapp, Christian Steinberg, Amir Janmohamed, Jean-Francois Roux, Danna Spears, Eugene Crystal, Zachary Laksman, Tom Hruczkowski, Angie Djuric, Kim Simek, Roberta Napoleoni, Brook Snider, Shun Fu Lee, Gloria Wong, Kailey Howell, Lauren Christmas, Svetlana Stoyanova-Brennecke, Kiran Qamar, Francois Lemarbre, Julie Lefebvre, Faye McCarthy, Ambreen Syeda, Nancy Page, Marina Sanchez, Marie-Christine Cote, Annette Nath, Pei Ying, Caitlin Patterson, Elisa Ramser, Nadia Vachon, Rebecca Cairns, Marta Gadacz, Melissa Braga Gomes
Journal: Annals of Internal Medicine (2022)

Implantable cardioverter defibrillators (ICDs) improve survival in patients at risk for cardiac arrest, but are associated with intravascular lead-related complications. The subcutaneous ICD (S-ICD), with no intravascular components, was developed to minimize lead-related complications.To assess key ICD performance measures related to delivery of ICD therapy, including inappropriate ICD shocks (delivered in absence of life-threatening arrhythmia) and failed ICD shocks (which did not terminate ventricular arrhythmia).Randomized, multicenter trial. (ClinicalTrials.gov: NCT02881255).The ATLAS trial.544 eligible patients (141 female) with a primary or secondary prevention indication for an ICD who were younger than age 60 years, had a cardiogenetic phenotype, or had prespecified risk factors for lead complications were electrocardiographically screened and 503 randomly assigned to S-ICD (251 patients) or transvenous ICD (TV-ICD) (252 patients). Mean follow-up was 2.5 years (SD, 1.1). Mean age was 49.0 years (SD, 11.5).The primary outcome was perioperative major lead-related complications.There was a statistically significant reduction in perioperative, lead-related complications, which occurred in 1 patient (0.4%) with an S-ICD and in 12 patients (4.8%) with TV-ICD (-4.4%; 95% CI, -6.9 to -1.9; P = 0.001). There was a trend for more inappropriate shocks with the S-ICD (hazard ratio [HR], 2.37; 95% CI, 0.98 to 5.77), but no increase in failed appropriate ICD shocks (HR, 0.61 (0.15 to 2.57). Patients in the S-ICD group had more ICD site pain, measured on a 10-point numeric rating scale, on the day of implant (4.2 ± 2.8 vs. 2.9 ± 2.2; P < 0.001) and 1 month later (1.3 ± 1.8 vs. 0.9 ± 1.5; P = 0.035).At present, the ATLAS trial is underpowered to detect differences in clinical shock outcomes; however, extended follow-up is ongoing.The S-ICD reduces perioperative, lead-related complications without significantly compromising the effectiveness of ICD shocks, but with more early postoperative pain and a trend for more inappropriate shocks.Boston Scientific.